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OpenTrials
Completed

NCT Number: NCT04105023

Genistein Stimulates Insulin Sensitivity Through Gut Microbiota

There is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (MetS). However, it is not known if this improvement is associated with changes in the gut microbiota. In the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with MetS. This effect will be accompanied by a modification of the gut microbiota taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.

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Key information

About this study

The investigators included 45 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of MetS, HOMA index greater than 2.5, BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Patients who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Participants were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months. In the previsit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. Also determined blood pressure, body weight, height, body composition and gut microbiota. The presence of insulin resistance was determined by means of the HOMA-IR index and by an oral glucose tolerance test. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then RNA extraction and gene expression microarray assay was performed

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (men and women) between the ages of 18 and 50.
  • Patients with obesity (BMI ≥ 30 and ≤ 40 kg / m2) and with insulin resistance (HOMA - IR Index ≥ 2.5).
  • Mexican mestizos (parents and grandparents born in Mexico).
  • Patients who can read and write.

Exclusion criteria

  • • Patients with any type of diabetes.
  • Patients with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or BUN> 20 mg / dL.
  • Patients with acquired diseases that produce obesity and diabetes secondarily.
  • Patients who have suffered a cardiovascular event.
  • Patients with weight loss > 3 kg in the last 3 months.
  • Patients with any catabolic diseases.
  • Gravidity status
  • Positive smoking
  • Treatment with any medication

Treatment and study plan

Genistein

Dietary Supplement

Administered orally once every 12 hours

Placebo

Dietary Supplement

Administered orally once every 12 hours

Primary outcomes

  1. intestinal microbiota

    Time frame: Baseline to 2 month

    Measurement of gut microbiota by sequencing using the Illumina platform

Secondary outcomes

  1. glucose metabolism profile

    Time frame: Baseline to 2 month

    serum glucose (mg/dL)

  2. Glucose metabolism profile

    Time frame: Baseline to 2 month

    serum insulin (µUI/ml)

  3. Triglycerides

    Time frame: Baseline to 2 month

    serum triglycerides (mg/dL)

  4. Total Cholesterol

    Time frame: Baseline to 2 month

    serum total cholesterol (mg/dL)

  5. LDL cholesterol

    Time frame: Baseline to 2 month

    serum LDL cholesterol (mg/dL)

  6. HDL cholesterol

    Time frame: Baseline to 2 month

    serum HDL cholesterol (mg/dL)

  7. Inflammatory profile

    Time frame: Baseline to 2 month

    plasma lipopolysaccharide (LPS) (ng/mL)

  8. Body weight

    Time frame: Baseline to 2 month

    body weight (kg)

  9. Blood pressure

    Time frame: Baseline to 2 month

    blood pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

Genistein Stimulates Insulin Sensitivity Through Gut Microbiota Reshaping and Skeletal Muscle AMPK Activation in Obese Subjects

Acronym: GENISTEIN

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2019
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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